Patients are increasingly being used as guinea pigs in the stem cell for-profit clinic world via what I call stem cell shot-in-the-dark procedures. The clinics have no logical basis for claiming that these treatments work and are safe.

As the number of stem cell clinics continues to grow in the US and more physicians add on unproven stem cell injections into their practices as a la carte options, far more patients are being subjected to risky, even reckless physician conduct.

Some of the clinic doctors that I talk to downplay the risks and tell me that since there haven’t been high-profile stem cell clinic-related lawsuits (at least that are known publicly) in the US that things are fine. This is going to change and inevitably patients are getting harmed by these clinics. There are just too many inexperienced medical personal doing shot-in-the-dark stem cell procedures that are not approved by the FDA. It’s an extremely dangerous situation.

By and large these clinics and the a la carte stem cell interventions sold by individual doctors out of their practices are subject in various ways to oversight by the FDA, but substantive FDA actions at least in the public domain have been essentially non-existent in recent years. I’m hoping this will change, but I’ve been hoping that for a few years.

Another dangerous component to this situation is that clinics are successfully finding new ways to recruit customers. There are also hints of legit institutions and individuals getting more linked to the stem cell clinic world and pushing against FDA regulation. This continuing muddying of the stem cell waters is an unsettling change.

What the clinics are doing with stem cell shot in the dark procedures is human experimentation to make money, which is pretty sickening both to observe and literally for some patients.

7 Comments

And yet there is the case of Governor Rick Perry, whose doctor used a yet-approved stem cell procedure for his back … and I think the results still hold.

It is so very difficult, when as a patient you have a very limited time left, to see and/or hear about those individuals who have connections to clinical trials that the rest of us don’t. So it is very tempting to volunteer as a lab rat. You have nothing to lose.

A fairly high profile US court case was the matter involving Biomark International which provided unproven, unregistered stem cell treatments consisting of the same types and amounts of stem cells notwithstanding the disease and made false advertising claims on their website in this regard. None of their patients recovered and many died. The owners were subsequently criminally indicted.

Knoepfleerr, what is also a shot in the dark is your utter lack of specifics and more hand waving as if you are privy to some secret information in your ‘hints’, which you are not, because people who are doing this are doing it out in the open, just like the academic institution are also engaging in shot in the same shot in the dark and making money out of clinical trials you call legitimate and ‘valid’.
How about instead of calling your blog “The Niche”, call it “The Bitch”, cos that comes through loud and clear more than any truth and substance in your blogs about private stem cell clinics.

The post looks like “religious” crusade against any attempt to bring innovation to public, repeating itself from many similar previous posts. By the way, Paul, not just in current post, but in your attitude to CRISPR too. Your TED talk is such misleading!
Of course there are charlatans, of course there are irresponsible practitioners. But it happens everywhere in medicine, which is pure business in US health care system, regardless it’s local hospital, medical office or respectful University. Patients are hurt by inappropriate time allocated by family doctor for medical assessment, by overdose, by unsafe approved drugs, by wrong decisions, by recklessness, everywhere! It’s so wrong to emphasize “stem cells” malpractice as unique medical filed, where patients are at risk.

@Nathan,
I’m not a very religious person and I’m not a crusader. I’m very excited about innovative biomedical technologies like stem cells and CRISPR, but I also feel strongly that there needs to be balance in discussions of risks both at individual and societal levels. In the stem cell world it is unfortunate, but in the last few years especially the number of stem cell clinics preying on patients has skyrocketed. This reality needs attention and discussion. – Paul